Transcatheter TricuspidTechnologies

Vinayak (Vinnie Bapat), FRCS.CTh

Assistant Professor of Surgery

Columbia University Medical Center

Tricuspid Valve "The Forgotten Valve"

In 1967, Braunwald et al advised

a conservative approach to TR.

“The present results indicate

that in such patients [functional

TR in patients with mitral valve

disease] tricuspid regurgitation

will improve or disappear after

mitral replacement and that

tricuspid valve replacement is

seldom necessary.”

Braunwald et al. Circulation 1967;35(supplI):63–9

TR cases

Annual New TR

Annual MR Surgeries

Annual TR Surgeries

1,600,000

250,000

50,000

5,500

TR is currently undertreated

Challenges with Tricuspid Regurgitation

• Assessment of symptoms1. Decreased CO – fatigue, decreased exercise tolerance

2. Right Heart Failure – Ascites, LE edema

• Assessment of TR Severity

Diagnostic Challenges with TR

• Regurgitation can be dynamic and very volume dependent

• Volume overload is well-tolerated for years

• Medical and surgical therapies are limited

• Poor understanding about grading the severity of TR on Echo

Extended Grading Scheme

Rebecca T. Hahn, and Jose L. Zamorano. “The Need for a New Tricuspid Regurgitation

Grading Scheme.” European Heart Journal - Cardiovascular Imaging, 2017

Severe Massive Torrential

Surgical Approaches to Tricuspid Regurgitation

De Vega PlastyModified De Vega Plasty

Asa

Ring AnnuloplastysdsdsdsdsdsdsdClover

Kay Plasty

New tricuspid therapies

Mechanism New Technologies

Annuloplasty(Direct and Indirect)

TriAlign Cardioband 4Tech Millepede

Leaflet Devices

Forma MitraClip

Stented Valves in IVC/SVC

Trinity /Sapien NVT

Valve Replacement

Navigate

Approaches:

1. Superior vena cava

2. Inferior vena cava

3. Transapical

4. Transatrial

Annular Devices

Bicuspidization of the TV with the Trialign System

J Am Coll Cardiol 2015;65:1190–5

Severe Isolated Primary Tricuspid Regurgitation

3D EROA3D

Annulus

3D EROA3D

Annulus

Baseline

13.9 cm2

7.6 cm2

(45% reduction)

0.99 cm2

0.43 cm2

(55% reduction)

Post-Trialign

Tricuspid Annular Area (cm2)

p = 0.019

12.3

11.3

10

10.5

11

11.5

12

12.5

Baseline 30 D

∆ 8%

1.02

0.75

0.00

0.20

0.40

0.60

0.80

1.00

Baseline 30 D

p = 0.048

TR Vena Contracta (cm) PISA EROA (cm2)

p = 0.020

0.51

0.32

0

0.1

0.2

0.3

0.4

0.5

Baseline 30 D

∆ 38%∆ 26%

SCOUT 30 Day DataAs-Treated‡*

‡ Change from baseline to 30 days computed on paired data* p-value by paired t-test or Wilcoxon as appropriate

(n=15) (n=15) (n=15)

Edwards Lifesciences Cardioband• Percutaneous band for developed mitral annulus to treat MR• A series of 15-18 anchors implanted in annulus• Performed a series of compassionate use cases in patients with tricuspid

regurgitation

Edwards Cardioband Tricuspid Repair Procedure

1Transfemoral

Approach2

System

Insertion3

Implant

Deployment4

Implant Size

Adjustment

Pre-Reduction Post-Reduction

Bonn University Hospital

Cardioband Tricuspid

Fluoroscopic View

44.4±4(34.8-52.2)

37±5(29.8-45.3)

20

25

30

35

40

45

50

Baseline DischargeSe

pto

late

ral D

iam

ete

r (m

m)

20

25

30

35

40

45

50

55

Baseline Discharge

Sep

tola

tera

l Dia

met

er (

mm

)

*P<0.01

N=26

Edwards TRI-REPAIR Study

17% average reduction in septolateral diameter by core lab

1.3

0.9

Baseline 30 Days

0.8±0.5

0.4±0.3

Baseline 30 Days

PIS

A E

RO

A (

cm2

)

60±20

64.7±12.4

, 64.7

Baseline 30 DaysN=17

Vena Contracta

P<0.001

• Large proportion of patients treated with “torrential TR”

• Improvements resulted in most patients achieving lower severity or

moderate TR at 30 days.

N=20

Ve

na

Co

ntr

acta

(c

m)

PISA EROA

P<0.001

Str

ok

e V

olu

me

(m

l)

LV Stroke Volume

P=0.06

N=18

Edwards TRI-REPAIR Study

50%31%

7%

The 4TECH TriCinch Concept

Hetzer Double Orifice Repair

91 patients with severe TR treated; mean follow- up of 4.1 years

(range 9 months, 19.4 years), no reoperation for recurrent TR

Hetzer R. et al, EJCTS 2013

TriCinch Coil System Procedural Steps

Leaflet Devices

FORMA Tricuspid Valve Therapy System(Edwards Lifesciences)

• Spacer

– Positioned within

regurgitant orifice

– Provides surface for native

leaflets to coapt

– 12, 15 and 18mm sizes

– Advanced from left

subclavian vein

• Rail

– Tracks Spacer into

position

– Anchored at RV apex and

subclavian vein

Case ExampleForma

2.1 ± 1.8

1.1 ± 0.9

1.1 ± 0.6

0.6 ± 0.4

FORMA Early Feasibility StudyEchocardiography Outcomes at 30 Days

(echo core lab)

64 consecutive patients (mean age 76.6±10 years)

Functional TR was present in 88%.

The degree of TR was severe or massive in 88% of patients before the procedure.

The MitraClip device was successfully implanted in the tricuspid valve in 97% of the cases.

Nickenig G et al Circulation. 2017;135:1802–1814.

Mitraclip for Treatment of Severe

Tricuspid Regurgitation

MitraClip For Functional TR

Modeling MitraClip for TR

Vismara, R. et al. J Am Coll Cardiol. 2016;68(10):1024–33.

Spacer is clasped between both Mitral valve leaflets

Independent leaflet clasping system

Simple “commander-like” delivery system

Conventional transfemoral/transseptal approach

Minimal dependence on puncture height

PAddles

Spacer

Clasps

ALfieri

Edwards Pascal Repair System

Caval Implants

J Am Coll Cardiol. 2013;61(18):1929-1931.

Michael Laule, Charité–Universitätsmedizin

Berlin, Campus Mitte, Germany

3 Patients

Sapien XT in IVC and SVC

Sapien in IVC

Sapien in IVC

What if the IVC is >30mm

Z stent used as scaffold

29mm S3 deployed with contrast injection to guide positioning

Sapien in IVC

Sapien in IVC

Sapien in IVC

Large IVC >35mm

External Ring to downsize IVC

Sapien 29 through Femoral Vein

Transcatheter Tricuspid Valve Replacement

Navigate Transcatheter

Valve

VALVED-STENT DIMENSIONS (mm)

Ventricular Ø

36 40 44 48 52

Atrial Ø

30 30 33 36 38

HEIGHT

20 18.2 19.4 22 21.4

• Presently 35F distal capsule OD

• 24F catheter shaft

• 80° Articulation

• Controlled Valve Release

• All modes of delivery use the same valve configuration

NAVIGATEValved Stent Delivery System

60

Surgical Access

• Right thoracotomy

• Right diaphragm retracted down to expose the site of the pure string

Valve release

Intra-procedural TEE –valve deployed

Right ventriculography post valve deployment

What has the early experience demonstrated?

• Patients often present with torrential TR

• Procedures are relatively safe

• ~50% reduction in EROA

• Improvement in clinical symptoms

• Durability is unclear

Next Steps

• Tricuspid Regurgitation Classification

• TR evaluation

• Understanding RV reserve

• Therapy in presence of PPM

• Repair vs Replacement